A Phase I Trial of Umbilical Cord Mesenchymal Stromal Cells for Acute Ischemic Stroke
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBOE Technology Group Co., Ltd.
About this trial
Study Methods: The trial consists of two phases, both including a placebo control.
Phase Ia (single-dose, dose-escalation): Three dose groups (low, medium, high) are set. This is a multicenter, randomized, double-blind, placebo-controlled, single-dose, dose-escalation trial. Dose escalation to the next level is permitted only after safety assessment at 28 days post-dose in the previous group.
Phase Ib (multiple-dose): Based on Phase Ia results, two dose groups will be selected. The product is administered on Day 0, Day 7, and Day 14 (3 doses total). The trial remains randomized, double-blind, and placebo-controlled.
Eligibility criteria
Qualifiers
Age ≥18 years, both genders included.
Clinical diagnosis of anterior circulation ischemic stroke, and able to receive the investigational product within 48 hours after the onset of stroke symptoms.
National Institutes of Health Stroke Scale (NIHSS) score of 6-20 (inclusive), with a score of <2 on item Ia of the NIHSS.
Pre-stroke modified Rankin Scale (mRS) score ≤1.
Disqualifiers
Planned or already performed thrombectomy for the current stroke.
Treatment with neuroprotective agents after the current stroke.
History of cerebral hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation after the current ischemic stroke, and judged by the investigator to be unsuitable for participation in the clinical trial.
Uncontrolled systemic diseases, including but not limited to: hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure ≥100 mmHg), diabetes mellitus (acute diabetic complications such as ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis, or hypoglycemic coma within the past 3 months, or glycated hemoglobin >8.5%, or poorly controlled blood glucose [blood glucose >16.8 mmol/L or <2.8 mmol/L]), renal disease (eGFR <30 mL/min), liver failure (Child-Pugh Class C), severe heart failure (New York Heart Association [NYHA] Class IV), severe chronic respiratory disease.
Trial design
Treatments tested in this trial
- Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection
- Human Umbilical Cord Mesenchymal Stem Cells Injection
- Human Umbilical Cord Mesenchymal Stem Cells Injection
Treatment groups
35 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov